-
1
-
-
59349103542
-
-
Carter, J. R.; Levy, R. V. Microbial Retention Testing in the Validation of Sterilizing 1.Filtration. In Filtration in the Biopharmaceutical Industry; Meltzer, T. H., Jornitz, M. W, Eds.; Marcel Dekker: New York, 1998.
-
Carter, J. R.; Levy, R. V. Microbial Retention Testing in the Validation of Sterilizing 1.Filtration. In Filtration in the Biopharmaceutical Industry; Meltzer, T. H., Jornitz, M. W, Eds.; Marcel Dekker: New York, 1998.
-
-
-
-
2
-
-
59349117547
-
-
Akers, J. A. Microbial Considerations in the Selection and Validation of Filter Sterilization. In Filtration and Purification in the Biopharmaceutical Industry; Meltzer, T H., Jornitz, M. W, Eds.; Informa Healthcare: New York, 2008.
-
Akers, J. A. Microbial Considerations in the Selection and Validation of Filter Sterilization. In Filtration and Purification in the Biopharmaceutical Industry; Meltzer, T H., Jornitz, M. W, Eds.; Informa Healthcare: New York, 2008.
-
-
-
-
3
-
-
0031893594
-
Bacterial Cell Size and Surface Charge Characteristics Relevant to Filter Validation Studies
-
Mittelman, M. W.; Jornitz M.; Meltzer, T. Bacterial Cell Size and Surface Charge Characteristics Relevant to Filter Validation Studies. PDA J. Pharm. Sci. Technol. 1998, 52, 37-42.
-
(1998)
PDA J. Pharm. Sci. Technol
, vol.52
, pp. 37-42
-
-
Mittelman, M.W.1
Jornitz, M.2
Meltzer, T.3
-
4
-
-
0032726509
-
Application of Membrane Filtration for Removal of Diminutive Bioburden Organisms in Pharmaceutical Products and Processes
-
Sundaram, S.; Auriemma, M.; Howard G.H., Jr.; Brandwein, H.; Leo, F. Application of Membrane Filtration for Removal of Diminutive Bioburden Organisms in Pharmaceutical Products and Processes. PDA J. Pharm. Sci. Technol. 1999, 53, 186-201.
-
(1999)
PDA J. Pharm. Sci. Technol
, vol.53
, pp. 186-201
-
-
Sundaram, S.1
Auriemma, M.2
Howard Jr., G.H.3
Brandwein, H.4
Leo, F.5
-
5
-
-
72849166275
-
Production and Control of a Stable Penicillinase
-
Bowman, F. W.; Holdowsky, S. Production and Control of a Stable Penicillinase. Antibiot. Chemother. 1960, 10, 508.
-
(1960)
Antibiot. Chemother
, vol.10
, pp. 508
-
-
Bowman, F.W.1
Holdowsky, S.2
-
7
-
-
59349099307
-
-
Aseptic Processing of Health Care Products - Part 2: Filtration, 3 Terms and Definitions 13408-2:2003 (E). ISO: 2003.
-
Aseptic Processing of Health Care Products - Part 2: Filtration, 3 Terms and Definitions 13408-2:2003 (E). ISO: 2003.
-
-
-
-
8
-
-
0018383313
-
Adsorptive Retention of Pseudomonas diminuta by Membrane Filters
-
Tanny, G. B.; Strong, D. K.; Presswood, W. G.; Meltzer, T. H. Adsorptive Retention of Pseudomonas diminuta by Membrane Filters. J. Parent. Drug Assoc. 1979, 33, 40-51.
-
(1979)
J. Parent. Drug Assoc
, vol.33
, pp. 40-51
-
-
Tanny, G.B.1
Strong, D.K.2
Presswood, W.G.3
Meltzer, T.H.4
-
9
-
-
0018988705
-
A Case of Penetration of 0.2μm Rated Membrane Filters by Bacteria
-
Howard, G.; Duberstein, R. A Case of Penetration of 0.2μm Rated Membrane Filters by Bacteria. J. Parent. Drug Assoc. 1980, 34, 93-102.
-
(1980)
J. Parent. Drug Assoc
, vol.34
, pp. 93-102
-
-
Howard, G.1
Duberstein, R.2
-
10
-
-
59349087884
-
-
Meeker, J.T.; Hickey, E.W.; Martin, J.M.; Howard, Jr., G. Technical Note: A Quantitative Method for Challenging 0.1 mm Rated Filters with A. laidlawii. Biopharm Intl. 1992, (March), 30.
-
Meeker, J.T.; Hickey, E.W.; Martin, J.M.; Howard, Jr., G. Technical Note: A Quantitative Method for Challenging 0.1 mm Rated Filters with A. laidlawii. Biopharm Intl. 1992, (March), 30.
-
-
-
-
11
-
-
0002214660
-
Methods Used to Validate Microporous Membranes for the Removal of Mycoplasma
-
May
-
Roche, K.L.; Levy, R. V. Methods Used to Validate Microporous Membranes for the Removal of Mycoplasma. BioPharm Intl. 1993, (May), 22-33.
-
(1993)
BioPharm Intl
, pp. 22-33
-
-
Roche, K.L.1
Levy, R.V.2
-
13
-
-
0029991844
-
Evaluation of Recovery Filters for Use in Bacterial Retention Testing of Sterilizing-Grade Filters
-
Carter, J. Evaluation of Recovery Filters for Use in Bacterial Retention Testing of Sterilizing-Grade Filters. PDA J. Pharm. Sci. Technol. 1996, 50, 147-163.
-
(1996)
PDA J. Pharm. Sci. Technol
, vol.50
, pp. 147-163
-
-
Carter, J.1
-
16
-
-
59349113014
-
-
Current Good Manufacturing Practice for Finished Pharmaceuticals. Code of Federal Regulations, Part 211, Title 21, 2007
-
Current Good Manufacturing Practice for Finished Pharmaceuticals. Code of Federal Regulations, Part 211, Title 21, 2007.
-
-
-
-
17
-
-
59349096099
-
-
Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs. Code of Federal Regulations. Part 210, Title 21, 2006
-
Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs. Code of Federal Regulations. Part 210, Title 21, 2006.
-
-
-
-
18
-
-
59349117676
-
-
<88> Biological Reactivity Tests, In Vivo. USP 31/NF 26. The United States Pharmacopeia Convention: Rockville, MD, 2007.
-
<88> Biological Reactivity Tests, In Vivo. USP 31/NF 26. The United States Pharmacopeia Convention: Rockville, MD, 2007.
-
-
-
-
19
-
-
59349090289
-
-
<87> Biological Reactivity Tests, In Vitro. USP 31-NF 26. The United States Pharmacopeia Convention: Rockville, MD, 2007.
-
<87> Biological Reactivity Tests, In Vitro. USP 31-NF 26. The United States Pharmacopeia Convention: Rockville, MD, 2007.
-
-
-
-
20
-
-
59349117307
-
-
Current Good Manufacturing Practice for Substances Prohibited from Use in Human Food. Code of Federal Regulations, Part 189, Title 21, 2007
-
Current Good Manufacturing Practice for Substances Prohibited from Use in Human Food. Code of Federal Regulations, Part 189, Title 21, 2007.
-
-
-
-
21
-
-
59349109946
-
-
Current Good Manufacturing Practice Requirements for Specific Cosmetic Products. Code of Federal Regulations, Part 700, Title 21, 2007
-
Current Good Manufacturing Practice Requirements for Specific Cosmetic Products. Code of Federal Regulations, Part 700, Title 21, 2007.
-
-
-
-
22
-
-
59349091653
-
-
Note for Guidance on Minimizing the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Human and Veterinary Medicinal Products, Section 6.4, Tallow Derivatives (EMEA/410/01 Revision 2). European Medicines Agency: 2004.
-
Note for Guidance on Minimizing the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Human and Veterinary Medicinal Products, Section 6.4, Tallow Derivatives (EMEA/410/01 Revision 2). European Medicines Agency: 2004.
-
-
-
-
23
-
-
0003091595
-
Model Stream Approach: Defining Worst Case Conditions
-
Stone, T.; Goel, V.; Leszczak, J.; Chrai, S. Model Stream Approach: Defining Worst Case Conditions. Pharm. Technol., 1996, 20(22), 34-51.
-
(1996)
Pharm. Technol
, vol.20
, Issue.22
, pp. 34-51
-
-
Stone, T.1
Goel, V.2
Leszczak, J.3
Chrai, S.4
-
24
-
-
0002677850
-
Extractables and Compatibilities of Filters
-
Meltzer, T. H, Jornitz, M. W, Eds, Marcel Dekker: New York
-
Reif, O. W. Extractables and Compatibilities of Filters. In Filtration in the Biopharmaceutical Industry; Meltzer, T. H., Jornitz, M. W., Eds.; Marcel Dekker: New York, 1998.
-
(1998)
Filtration in the Biopharmaceutical Industry
-
-
Reif, O.W.1
-
25
-
-
59349119389
-
Understanding Membrane Plugging Mechanisms, Microelectronics Application Note MAL 116
-
White Paper. 1-22
-
Clarke, M. E.; Zahka, J. Understanding Membrane Plugging Mechanisms, Microelectronics Application Note MAL 116. Mykrolis, 2000, White Paper. 1-22.
-
(2000)
Mykrolis
-
-
Clarke, M.E.1
Zahka, J.2
-
26
-
-
2642705852
-
-
Fennington, Jr. G. J.; Howard, Jr. G. Preparation and Evaluation of Bacterial Stocks for Filter Validation. PDA J. Pharm. Sci. Technol. 1997, 51, 153-155.
-
Fennington, Jr. G. J.; Howard, Jr. G. Preparation and Evaluation of Bacterial Stocks for Filter Validation. PDA J. Pharm. Sci. Technol. 1997, 51, 153-155.
-
-
-
-
27
-
-
0002556170
-
Validation of Bacterial Retention Capabilities of Membrane Filters
-
Leahy, T. J.; Sullivan, M. Validation of Bacterial Retention Capabilities of Membrane Filters. Pharm. Technol. 1978, 2(11), 64-75.
-
(1978)
Pharm. Technol
, vol.2
, Issue.11
, pp. 64-75
-
-
Leahy, T.J.1
Sullivan, M.2
-
28
-
-
0004200674
-
-
Meltzer, T. H, Jornitz, M. W, Eds, Marcel Dekker: New York
-
Meltzer, T. H. Filtration in the Pharmaceutical Industry; Meltzer, T. H., Jornitz, M. W., Eds.; Marcel Dekker: New York, 1987.
-
(1987)
Filtration in the Pharmaceutical Industry
-
-
Meltzer, T.H.1
-
29
-
-
0033795802
-
Considerations on Using 'Bubble Point' Type Tests as Filter Integrity Tests, Part I
-
Sundaram S.; Brantley, J.D.; Howard, Jr. G.; Brandwein, H. Considerations on Using 'Bubble Point' Type Tests as Filter Integrity Tests, Part I. Pharm. Technol. 2000, 24(9), 90-115.
-
(2000)
Pharm. Technol
, vol.24
, Issue.9
, pp. 90-115
-
-
Sundaram, S.1
Brantley, J.D.2
Howard Jr., G.3
Brandwein, H.4
-
30
-
-
0033744055
-
-
Sundaram S.; Brantley, J.D.; Howard, Jr. G.; Brandwein, H. Part II: Effect of Filter Area on 'Bubble Point' Measurements and Implications for the Use of 'Bubble Point' Type Tests as Correlated Tests. Pharm. Technol. 2000, 24(10), 108-136.
-
Sundaram S.; Brantley, J.D.; Howard, Jr. G.; Brandwein, H. Part II: Effect of Filter Area on 'Bubble Point' Measurements and Implications for the Use of 'Bubble Point' Type Tests as Correlated Tests. Pharm. Technol. 2000, 24(10), 108-136.
-
-
-
-
31
-
-
0003220445
-
Bacteria Removal Prediction in Membrane Filters
-
Presented at, University of Tennessee, Knoxville, TN, June
-
Pall, D. B.; Kirnbauer, E. A. Bacteria Removal Prediction in Membrane Filters. Presented at 52nd Colloid and Surface Science Symposium, University of Tennessee, Knoxville, TN, June 1978.
-
(1978)
52nd Colloid and Surface Science Symposium
-
-
Pall, D.B.1
Kirnbauer, E.A.2
-
32
-
-
0017508447
-
An Assessment of Test Criteria for Evaluation the Performance and Integrity of Sterilizing Filters
-
Reti, A. R. An Assessment of Test Criteria for Evaluation the Performance and Integrity of Sterilizing Filters. Bull. Parent. Drug Assoc. 1977, 31, 187-193.
-
(1977)
Bull. Parent. Drug Assoc
, vol.31
, pp. 187-193
-
-
Reti, A.R.1
-
36
-
-
0038537504
-
Integrity Testing
-
Meltzer, T. H, Jornitz, M. W, Eds, Marcel Dekker: New York
-
Jornitz, M. W., Trotter, A. M., Meltzer, T. H. Integrity Testing. In Filtration in the Biopharmaceutical Industry; Meltzer, T. H., Jornitz, M. W., Eds.; Marcel Dekker: New York, 1998.
-
(1998)
Filtration in the Biopharmaceutical Industry
-
-
Jornitz, M.W.1
Trotter, A.M.2
Meltzer, T.H.3
-
37
-
-
0035074231
-
Investigation of a Filter Structure by Microbial Retention Studies: A Synthesis and Elaboration of Prior Findings
-
Trotter, A. M.; Meltzer, T. H., et al. Investigation of a Filter Structure by Microbial Retention Studies: A Synthesis and Elaboration of Prior Findings. PDA J. Pharm. Sci. Technol. 2001, 55, 127-133.
-
(2001)
PDA J. Pharm. Sci. Technol
, vol.55
, pp. 127-133
-
-
Trotter, A.M.1
Meltzer, T.H.2
-
38
-
-
0025203028
-
Steam Sterilization-In-Place Technology
-
Agalloco, J. P. Steam Sterilization-In-Place Technology. PDA J. Pharm. Sci. Technol. 1990, 44, 253-256.
-
(1990)
PDA J. Pharm. Sci. Technol
, vol.44
, pp. 253-256
-
-
Agalloco, J.P.1
-
40
-
-
0020131569
-
Steam-In-Place Sterilization of Cartridge Filters In-Line with a Receiving Tank
-
Myers, T.; Chrai, S. Steam-In-Place Sterilization of Cartridge Filters In-Line with a Receiving Tank. J. Parent. Sci. Tech. 1982, 36, 108-112.
-
(1982)
J. Parent. Sci. Tech
, vol.36
, pp. 108-112
-
-
Myers, T.1
Chrai, S.2
-
41
-
-
0006875594
-
Operational Considerations in the Steam Sterilization of Cartridge Filters
-
Steere, W.; Meltzer, T. H. Operational Considerations in the Steam Sterilization of Cartridge Filters. Pharm. Technol. 1993, 9, 98-110.
-
(1993)
Pharm. Technol
, vol.9
, pp. 98-110
-
-
Steere, W.1
Meltzer, T.H.2
-
42
-
-
59349094937
-
-
Sterilization of Health Care Products - Radiation, Part 1: Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices, 11137-1:2006. ANSI/AAMI/ ISO: 2006.
-
Sterilization of Health Care Products - Radiation, Part 1: Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices, 11137-1:2006. ANSI/AAMI/ ISO: 2006.
-
-
-
-
45
-
-
59349119390
-
-
Note for Guidance on Development Pharmaceutics (CPMP (CPMP/QWP/ 155/96). European Medicines Agency: 1998.
-
Note for Guidance on Development Pharmaceutics (CPMP (CPMP/QWP/ 155/96). European Medicines Agency: 1998.
-
-
-
-
46
-
-
59349086619
-
-
Decision Tree for Selection of Sterilisation Methods (CPMP/QWP/ 054/98 Corr.), Annex to Note for Guidance on Development Pharmaceutics (CPMP/QWP/155/96). European Medicines Agency: 2000.
-
Decision Tree for Selection of Sterilisation Methods (CPMP/QWP/ 054/98 Corr.), Annex to Note for Guidance on Development Pharmaceutics (CPMP/QWP/155/96). European Medicines Agency: 2000.
-
-
-
-
48
-
-
59349085732
-
-
ANSI/AAMI/ISO. Medical devices - Validation and Routine Control of Ethylene Oxide Sterilization, 11135:1994.
-
ANSI/AAMI/ISO. Medical devices - Validation and Routine Control of Ethylene Oxide Sterilization, 11135:1994.
-
-
-
-
49
-
-
59349087473
-
BioProcess Systems Alliance Component Quality Test Matrices
-
BPSA Guidelines and Standards Committee
-
BPSA Guidelines and Standards Committee. BioProcess Systems Alliance Component Quality Test Matrices. BioProcess Intl., 2007, 5(4), 52-57.
-
(2007)
BioProcess Intl
, vol.5
, Issue.4
, pp. 52-57
-
-
-
50
-
-
0021222567
-
Integrity Testing of Microfiltration Membranes
-
Hofmann, F. Integrity Testing of Microfiltration Membranes, J. Parent. Sci. Tech., 1984, 148-159.
-
(1984)
J. Parent. Sci. Tech
, pp. 148-159
-
-
Hofmann, F.1
-
51
-
-
59349105140
-
-
Emory, S. F. Principles of Integrity-Testing Hydrophilic Microporous Membrane Filters, Part I, II. Pharm. Technol. 1989, 9, 68-77; 10, 36-46.
-
Emory, S. F. Principles of Integrity-Testing Hydrophilic Microporous Membrane Filters, Part I, II. Pharm. Technol. 1989, 9, 68-77; 10, 36-46.
-
-
-
-
52
-
-
0034763775
-
Filter Integrity Testing in Liquid Applications, Revisited, Part 1
-
October
-
Jornitz, M. W., et al. Filter Integrity Testing in Liquid Applications, Revisited, Part 1. Pharm. Technol. 2001, October, 34-50.
-
(2001)
Pharm. Technol
, pp. 34-50
-
-
Jornitz, M.W.1
-
53
-
-
0034763775
-
Filter Integrity Testing in Liquid Applications, Revisited, Part 2
-
October, 24-35
-
Jornitz, M. W., et al. Filter Integrity Testing in Liquid Applications, Revisited, Part 2. Pharm. Technol. 2001, October, 24-35.
-
(2001)
Pharm. Technol
-
-
Jornitz, M.W.1
|